Product Director, Regulatory

Role Overview

The distinct behaviour demonstrated by the Product Director Regulatory is defined by Product Thought Leadership, Innovation, Strategy and People Management & Development. The Product Director for Regulatory, within GSK R&D Tech, is accountable for designing and delivering the roadmap for a range of Regulatory products with a focus on working collaboratively with senior stakeholders to understand and deliver against the GSK Regulatory Strategy.

The role will have ownership and responsibility for partnering with business owners to shape and create the vision for technology used to submit new regulatory applications and maintain GSK licences worldwide. This includes defining product roadmaps and investments, and overseeing internal and managed service teams to deliver against the vision and strategy. Experience of Regulatory systems such as Veeva RIM is desired, as is experience of data management, analytics tools and process automation and regulatory intelligence management platforms.

The Product Director Regulatory is recognized as the go to leader and trusted advisor for products supporting Regulatory Affairs, other R&D functions and interfaces with Supply Chain – removing blockers, working collaboratively and adaptively to constantly meet the needs of their customers and deliver value to GSK.

About R&D Tech and Regulatory at GSK

GSK R&D is ambitious for patients, and Regulatory Affairs is driving to reduce submission cycle times and effort and delivering high quality, right first time submissons in support of Clinical, Safety, initial marketing applications and maintenance submissions globally.

GSK has invested heavily in foundational platforms such as Veeva RIM and also in building a data fabric to support sharing of data across the organisation and industry leading platforms for automated authoring. This presents great opportunity for further Tech enablement via investments in modern platform and data technologies.

The R&D Tech Product Director responsibilities include the following:

• Technology Strategy & Enablement: in the role of trusted advisor, strong domain knowledge including business process, industry best practices, in market solutions.  Maintains awareness of emerging industry trends related to the product space and uses the knowledge to drive forward looking product strategy.

• Demand management: Collaborate and influence senior business stakeholders to manage and prioritize the product backlog with a focus on highest business value.  Accountable for the product backlog and product cost forecast.

• Governance: Establish and lead relevant governance bodies (steering committees), provide oversight and establish business value, manage overall delivery and service performance and manage business risk.

• Product/Project Delivery: Lead the team(s) that will design and deliver the optimal set of products and services which meets the business strategy and requirements. Accountable for creation and execution of the product roadmap. The ability to think big picture and customer first is imperative.

• Quality, Risk & Compliance: Accountable for ensuring all products supporting the business are compliant with internal security, risk management policies and practices, external regulatory and statutory requirements e.g. GxP, and that Tech continuity plans are in place for all business-critical products.

• Feature Definition: Proven ability to translate customer requests, competitive activities, and industry trends into value drivers of new technology solutions and product requirements that can be easily understood by product teams, developers and other key constituencies within the organization.

• Service Management: Accountable for ensuring the right services levels are in place, to ensure adherence to those SLAs, and directly manage any Level 3 Support issues and escalations.  Accountable for Life Cycle management of the products.

• People Management: Will work in collaboration with the broader team to drive and deliver business value to tight timelines adhering to the release management calendar where applicable.

• Adoption strategy & change management: in the role of change agent, support both the product teams and the business in agile approaches to solution development and adoption, building excitement, momentum, visible success stories and clear value-based versions of vision as roadmap plans come to life.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Bachelors Degree &/or comparable experience in computer science or related technical discipline

• Track record in successful IT strategy development, solution design, programme and project delivery and service management, across multiple business lines.

• Track record in delivering business impact through process and IT enabled solutions, across multiple business lines

• Domain knowledge of Regulatory processes and systems

Preferred Qualifications

• Experience in Regulatory Processes and Platforms, for example Regulatory Information Management Systems such as Veeva RIM, submission publishing (eCTD, non-eCTD) Regulatory Intelligence

• Strong track record of Product Management in a major global IT organization delivering change through Agile teams

• Experience of vendor management

• Track record in effective line management

• Strong facilitation, communication, and interpersonal skills, ability to influence senior. leadership and decision making using data, market evidence

• Relentless focus on delivering business outcomes and value and simplification with a passion for science and advancing medicines to patients

• Experience in managing delivery of solutions in a GxP context, and ability to partner with Risk Management, Audit and QA functions to deliver high quality, compliant solutions

• Size, scope and scale of challenge necessitates a leader with the right proven experiences, strategic thinking and execution capabilities. Credibility (through experience) is essential to success in these roles

Interested in Joining the Team?

Please apply via our online portal providing your CV and Cover Letter.
(Please take a personal copy of the Job Description, as this will not be available online post closure of the advert)

Closing Date: 21st November 2024

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We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.

We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).

We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on [email protected] or 0808 234 4391. 

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